Job Description

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Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. We are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Find the opportunity to build relevant career, be creative, and try new things with the support needed to be successful. Find the Danaher Business System, which makes everything possible.

We hope youll see yourself here, too. What you find at Beckman Coulter and within yourself might just change the world!

The Regulatory Affairs Specialist for Beckman Coulter Diagnostics is responsible product clearances, regulatory submissions, and global strategies using your regulatory and design controls experience. You'll apply your experience interpreting global medical device regulations as they apply to our products, processes and/or procedures, advise on impact of regulations, and devise strategies for compliance.

This position is a member of the Beckman Coulter Regulatory Affairs Team and will be located in Miami, Florida. The Miami RA team supports the Hematology, Urinalysis, and Flow Cytometry business units to develop, lead, and integrate Beckman Coulters regulatory strategies and programs.

You will be a part of the Miami RA team and report to the Senior Manager of Regulatory Affairs responsible for product clearances, assessing regulatory impact of design changes, audit support and regulatory strategy. If you thrive in a multifunctional, global, fastpaced, supporting role and want to work to build a world-class Regulatory Affairs organizationread on.

In this role, you will have the opportunity to:

* Collaborate with Program Managers and technical staff cross functional project teams to provide regulatory strategy for devices
* Review marketing material for regulatory compliance
* Assist with clearance of new products or changes in existing products in the USA and other global marketplaces.
* Apply and/or complete various certificates and the legalization, Apostille and notarization process.
* Provide regulatory oversight in support of design changes.

The essential requirements of the job include:

* Bachelor's degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering
* Experience with medical device development process, design changes and design controls.
* Experience with preparing registration documentation for FDA premarket submissions, Health Canada device registration and global health ministries.

It would be a plus if you also possess previous experience in:

* Knowledge of EU IVDR regulations.
* Working with cross-functional product development teams.

Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates lives. Whether its a health care program or paid time off, our programs enhance life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Work hard and with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of Danaher's 67,000 associates across the globe, the possibilities for growth and development are unparalleled.

We believe that creativity and innovation thrive when the most diverse set of voices are heard, and thats why were taking concrete steps to ensure that were fostering an inclusive and engaging workplace. To learn more, read about our associates on our Careers Blog or contact one of our recruiters.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.